MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLSTENT¿ RP ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number M001711280

Device Problems Failure to Capture (1081); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the sheath fractured and the stent was not fully reconstrained prior to removal.The severely stenosed target lesion was located in the biliary tract.A 8x60x75/ 6f wallstent¿ rp endoprosthesis stent was advanced to treat the lesion.However, it was noted that the outer sheath fractured while the stent was deployed partially.The device was directly removed from the patient and the procedure was completed with another of the same device.No patient complications were reported and the patient¿s status was stable.

Manufacturer Narrative

Device evaluated by mfr.: device analysis identified a complete break on the blue outer catheter.The stent of the device was not mounted on the delivery system and was not returned for analysis.During a visual and tactile examination a complete break of the blue outer catheter was noted located at approximately 30mm distal of the main valve.A visual and tactile examination identified no issues with the tip of the device.A visual and microscopic examination identified no issues with the stent holder or stent cups of the returned device.No further issues were identified during product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that the sheath fractured and the stent was not fully reconstrained prior to removal.The severely stenosed target lesion was located in the biliary tract.A 8x60x75/ 6f wallstent rp endoprosthesis stent was advanced to treat the lesion.However, it was noted that the outer sheath fractured while the stent was deployed partially.The device was directly removed from the patient and the procedure was completed with another of the same device.No patient complications were reported and the patient¿s status was stable.

• Brand Name: WALLSTENT¿ RP ENDOPROSTHESIS
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7579217
• MDR Text Key: 110462124
• Report Number: 2134265-2018-05076
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K992510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2019
• Device Model Number: M001711280
• Device Catalogue Number: 71-128
• Device Lot Number: 20626254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2018
• Initial Date FDA Received: 06/07/2018
• Supplement Dates Manufacturer Received: 06/22/2018
• Supplement Dates FDA Received: 07/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1